The work aimed to study a new mucoadhesive prolonged release tablet containing 24 μg clobetasol-17 propionate (CP) suitable for the management of oral lichen planus. Low swellable dosage forms were designed by combining a mucoadhesive polymer , i.e. poly(sodium methacrylate, methylmethacrylate), with hydroxypropylmethylcellulose and MgCl2. This formulation was selected to modify the tablet erosion rate in order to obtain a release of CP over a 6 h period. A double-blind controlled study was performed using three groups of patient (n=16) which received 3 applications-a-day over 4 weeks of the developed CP tablets (group CP-T), placebo tablets (group CP-P) or commercial CP ointment for cutaneous application (123 μg/application) extemporary mixed with OrabaseTM (group CP-O). At the end of the study, pain and ulceration resolved in 13/16 and 11/16 patients of group CP-T and group CP-O, respectively. In the group CP-O, a transient acute hyperaemic candidosis (n=2) and taste alteration (n=4) were also observed. No changes in clinical signs of partients in the group CP-P were evident. The application of mucoadhesive tablet containing 24 μg CP 3 times-a-day appeared to be effective, avoiding the side-effects of the generally used treatment.
A new mucoadhesive dosage form for the management of oral lichen planus: formulation study and clinical study / F. Cilurzo , C.G.M. Gennari , F. Selmin, J.B. Epstein, G.M. Gaeta, G. Colella, P. Minghetti. - In: EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS. - ISSN 0939-6411. - 76:3(2010 Nov), pp. 437-442.
|Titolo:||A new mucoadhesive dosage form for the management of oral lichen planus: formulation study and clinical study|
CILURZO, FRANCESCO (Primo)
GENNARI, CHIARA GRAZIA MILENA (Secondo)
MINGHETTI, PAOLA (Ultimo)
|Parole Chiave:||Mucoadhesive tablet; Oral lichen planus; Topical corticosteroids|
|Settore Scientifico Disciplinare:||Settore CHIM/09 - Farmaceutico Tecnologico Applicativo|
|Data di pubblicazione:||nov-2010|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1016/j.ejpb.2010.07.014|
|Appare nelle tipologie:|